Evaluation of the Effect of Robot-assisted Early Mobilization - Project MobiStaR

Patient Activation Clinical Trial

— MobiStaR  

Official title:

Evaluation of the Effect of Robot-assisted Early Mobilization on Critically Ill Patients, on the Mobilisation Behaviour and Experience of Mobilizing Professionals and Organisational Processes in an Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071248
• Other study ID #: 16SV842
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: October 2023
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Within the MobiStaR project the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to increase the mobilization rate of critically ill intensive care patients significantly, possibly thereby increasing the rehabilitation outcomes for these patients and developing a new standard of care for robot-assisted early mobilization.

The intervention study will assess the organizational feasibility of robot-assisted early mobilization (starting in the first 72 hours after admission to the ICU), the behavior and experience of the mobilizing professionals and the effects on patient outcomes in terms of ventilation time, muscle mass (sonographic examination) and physical activity (measured by established scores such as Functional Status Score for ICU (FSS-ICU) and Medical Research Council (MRC) classification).

Description:

Early mobilization means the mobilization of critically ill patients in the early course after admission to the intensive care unit. The positive influence of early mobilization of critically ill patients on various aspects of patient outcomes has already been demonstrated. However, the implementation of early mobilization in clinical practice is difficult. Especially the high personnel effort is a barrier.

The Munich-based company Reactive Robotics (RR) is currently developing the world's first adaptive robotic assistance system VEMO©, which has CE approval for the planned indication and is to be used in the medium term for mobilizing intensive care patients.

Within the MobiStaR project, the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to significantly increase the mobilization rate of critically ill intensive care patients, possibly thereby increasing the rehabilitation results for these patients and developing a new standard of care for robot-assisted early mobilization. In this project, the robotic system will be used in anesthesiology intensive care units of the Ludwigs-Maximilians-University hospital.

Within this study, the effects of robot-assisted early mobilization will now be evaluated. This study comprises three study arms, in which (1) the feasibility and practicability of robot-assisted early mobilization, (2) the behavior and experience of the mobilizing professionals, and (3) the effect on patient outcomes will be evaluated.

The study is monocentric, prospective, interventional, does not include invasive procedures or blood sampling and has multiple data collection time points.

1. The feasibility of robot-assisted early mobilization surveys concomitantly how many VEM therapies can be implemented in how many patients as well as if and which adverse events occur.

2. The behavior and experience of the mobilizing professionals will be evaluated by using episodic interviews and standardized observations. Nurses with advanced training in anesthesia and intensive care, nurses and physiotherapists who have at least three years of professional experience in an intensive care unit as well as medical specialists with completed specialist training or a leading position in the intensive care unit will be included.

3. The effects on patient outcomes, primarily ventilation duration, muscle mass (sonographic examination) and physical activity (measured by established scores such as FSS-ICU and MRC classification), will be measured at different time points and compared with a historical patient population. Secondary factors such as delirium incidence, hemodynamic parameters, respiratory parameters but also longitudinal parameters such as ICU and hospital length of stay will be analyzed from routine data/patient records. Informed consenting patients undergoing a planned surgical procedure that is postoperatively associated with intensive care treatment and an anticipated duration of ventilation of more than 48 hours will be included. These patients will receive standardized early mobilization using the robotic system at either ten frequencies or for seven days. No invasive procedures such as blood sampling will be performed as part of the study. Outcomes will be compared with a historical comparison group to evaluate the effect of robot-assisted VEM (very early mobilization). Approximately 30 patients will be included. The outcomes will be compared with those of a historical group (n=30) treated with conventional early mobilization.

The intervention is planned for a duration of five to six months starting in September 2021.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• planned surgical intervention

• postoperative intensive medical and therapeutic treatment

• expected duration of ventilation > 48 hours

• age = 18 years

• preoperative informed consent by the patients in the study

• weight >45 kg and <135 kg

• body height >1.50 m and <1.95 m

Exclusion Criteria:

• patient refusal to participate in the study

• unable to give consent

• chronically bedridden before inclusion

• clinical Frailty Scale = 7

• chronic ventilation (over 24h) before ICU admission

• increased intracranial pressure / risk for increased intracranial pressure / recent cerebral hemorrhage

• pregnancy

• pre-existing neuromuscular disease resulting in chronic limitation of strength and efficiency

• sternotomy / sternectomy during surgical procedure

Related Conditions & MeSH terms

• Mobilization
• Patient Activation
• Robotics

Intervention

Device:
• VEMO (Reactive Robotics GmbH)
The robot used for early mobilization is able to verticalize the patients in their bed without transfer and to generate a movement of the legs that measures and supports the patients' own movement. The device meets the requirements for mobilizing critically ill patients in an intensive care unit, maintaining hygiene standards and providing the best possible support for the patient's own movement.

Locations

Country	Name	City	State
Germany	LudwigMaximilians	Munich	BY

Sponsors (3)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Catholic University of Eichstätt-Ingolstadt, German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration	changes in ventilation duration (in hours) in comparison to a historical patient group	6 months
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination Area of the M.rec.femoris	muscle mass (sonographic examination, in millimeters): Area of the M. rec. femoris in comparison to a historical patient group (in cm²)	6 months
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness M. quad. femoris	muscle mass: Thickness M. quad. Femoris (in cm²) in comparison to a historical patient group	6 months
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination- motility diaphragm breathing	muscle mass: motility of the diaphragm during breathing (in cm) in comparison to a historical patient group	6 months
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm inspiration	muscle mass: Thickness of diaphragm during inspiration (in cm) in comparison to a historical patient group	6 months
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm exhalation	muscle mass: Thickness of diaphragm during exhalation (in cm) in comparison to a historical patient group	6 months
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity - FSS-ICU	physical activity measured using the score FSS-ICU (0 -35) in comparison to a historical patient group. A higher value means a better outcome.	6 months
Primary	Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity	physical activity on upper and lower extremity measured using the Medical Research Council (MRC) score in comparison to a historical patient group. (0=absent muscle contraction, 1=visible muscle contraction, 2=movement when gravity is eliminated, 3=active movement against gravity, 4=active movement against resistance, 5=normal strength.)	6 months
Primary	Behavior and experience of the mobilizing professionals - qualitative interviews	subjectively experienced emotions, motivating and challenging factors - evaluated with a semi-structured interview guideline	6 months
Primary	Behavior and experience of the mobilizing professionals - qualitative observations	behavior and body posture during the mobilization - evaluated with a standardized observation sheet	6 months
Primary	Feasibility in organizational processes - eligible patients	Frequency of eligible patients (count per week: included patients in the study/ new eligible patients in the ICUs)	6 months
Primary	Feasibility in organizational processes - mobilizations	frequency of robot-assisted mobilizations (per patient per day)	6 months
Primary	Feasibility in organizational processes - adverse events	adverse events (count of patient-related, user-related or technology-related adverse events)	6 months
Secondary	Delir	Delir incidence using the CAM ICU: number of days without Delir. 1 = pathological; 2 = normal; 3 = not performed in comparison to a historical patient group	6 months
Secondary	Consciousness	level of consciousness using the Glasgow Coma Scale (3-15) in comparison to a historical patient group	6 months
Secondary	Sedation level	Sedation level using the Richmond Agitation Sedation Scale (RASS) (-5 - +5) in comparison to a historical patient group	6 months
Secondary	Pain (VAS)	Pain - with the use of the Visual Analog Scale (VAS) (before and after mobilization) (0-10) in comparison to a historical patient group	6 months
Secondary	health related quality of life	Health-related quality of life after 3 months using the the SF-36 (Short form questionnaire) (0-100) in comparison to a historical patient group	6 months
Secondary	Blood pressure	hemodynamics - Blood pressure (in mmHg) in comparison to a historical patient group	6 months
Secondary	catecholamine demand	hemodynamics - catecholamine demand (cumulative over 24 hours) in comparison to a historical patient group	6 months
Secondary	heart rate	hemodynamics - heart rate (1/min) in comparison to a historical patient group	6 months
Secondary	cardiac output	hemodynamics - Cardiac output (in l/min) in comparison to a historical patient group	6 months
Secondary	oxygen consumption	hemodynamics - Oxygen consumption (in l) in comparison to a historical patient group	6 months
Secondary	respiration	respiration- Maximum respiratory rate for 24h in comparison to a historical patient group	6 months
Secondary	ICU Score - SOFA	ICU Scores like Sepsis-related organ failure assessment score (SOFA) (0-24) in comparison to a historical patient group. A higher value means a worse outcome.	6 months
Secondary	ICU Scores - APACHE II	ICU Scores like Acute Physiology and Chronic Health Disease Classification System II (APACHE II) (0-71) in comparison to a historical patient group. A higher value means a worse outcome.	6 months
Secondary	ICU Scores - SAPS II	ICU Scores like Simplified Acute Physiology Score II (SAPS II) (0-163) in comparison to a historical patient group. A higher value means a worse outcome.	6 months